452BENEFIT-RISK ASSESSMENT OF CALCITONIN SALMON USING POST-APPROVAL SURVEILLANCE DATA TO CONCLUDE THE SAFETY OF CALCITONIN NASAL SPRAYCalcitonin salmon is a single chain polypeptide containing 32 amino-acid residues, which is used for the treatment of postmenopausal osteoporosis, hypercalcaemia, Paget’s disease, bone metastases, phantom limb pain, and spinal stenosis. However, Calcitonin-containing medicines are recommended for short-term treatment as the long-term use is associated with an increased risk of cancer. The primary aim of the study was conducted benefit-risk assessment of calcitonin salmon using postapproval surveillance data to conclude the safety of calcitonin nasal spray. Calcitonin (salmon) nasal solution is more potent and longer acting, as it exhibits greater affinity to receptor binding sites than calcitonin from mammalian species, including the synthetic human calcitonin. In terms of bioactivity, the potency of calcitonin (salmon) nasal solution was found to be about half that of the drug given by intramuscular or subcutaneous injection. Calcitonin (salmon) was non-mutagenic on Salmonella typhimurium (5 strains), Escherichia coli (2 strains) and mammalian V79 cells of the Chinese Hamster. Calcitonin (salmon) is effective in postmenopausal osteoporosis and Paget’s disease. The available evidence from AERS database, Health Canada’s Med-effect database and literature review does not suggest an alteration in risk: benefit balance of calcitonin nasal spray. However acknowledging the limitations of the data and in view of the regulatory authorities review and findings of increased risk of cancer in uses of calcitonin nasal spray in postmenopausal women. The report establishes the safety of Calcitonin nasal spray under its recommended conditions of usekrishnan_kiran@hotmail.comResearch542014Benefit-Risk Assessment,Calcitonin Nasal Spray, Calcitonin Salmon,Osteoporosis,Postmenopausal WomenKiran Krishnan,Kathiresan KrishnasamyDepartment of Pharmacy, Annamalai University, Chidambaram, Tamil Nadu, India,Department of Pharmacy, Annamalai University, Chidambaram, Tamil Nadu, India